MAUDE Adverse Event Report: DEPUY IRELAND 9616671 GLOBAL UNITE STD STEM SZ 12; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	110012100
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient presented in dr.S office with a painful right shoulder that dr had treated on (b)(6) 2016 for a four part proximal humeral fracture.Dr.Suspected a possible infection and elected to perform a two stage shoulder revision.On (b)(6) 2019, dr removed index components at (b)(6) and inserted a handmade antibiotic cement spacer.The cemented humeral stem assembly came out clean without any cement attached by hand.Unknown cement was used at time of index surgery.Dr used standard delta extend instrumentation to remove the glenosphere and metaglene that were well fixed.No instrumentation broke during surgery.There were no time delays.And there was no indication by dr or staff that the products were deficient or the reason for the need for revision.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLOBAL UNITE STD STEM SZ 12
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8837048
• Report Number: 1818910-2019-99546
• Device Sequence Number: 2078700
• Product Code: HSD
• UDI-Device Identifier: 10603295004127
• UDI-Public: 10603295004127
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110012100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 09/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR